Closed urinary drainage and irrigation system

ABSTRACT

A closed system, disposable, urinary drainage and irrigation system having the following improvements: 1. A FLEXIBLE DRAINAGE TUBE OF INCREASED INTERNAL DIAMETER, WHICH IS LARGER THAN THE MAXIMUM INTERNAL DIAMETER AT WHICH A CONTINUOUS COLUMN OF URINE WILL FORM IN THE TUBE WHEN URINE FLOWS THERETHROUGH BY GRAVITY FROM THE BLADDER, TO THEREBY PREVENT MICROORGANISMS FROM ASCENDING THE TUBE TO THE BLADDER; 2. A CIRCUMFERENTIAL SLIT EXTENDING PART WAY AROUND THE CIRCUMFERENCE OF THE DRAINAGE TUBE LOCATED OVER THE SHANK OF THE CATHETER ADAPTER TO PROVIDE A UNIQUE TYPE IRRIGATION VALVE FOR ALTERNATELY IRRIGATING THE BLADDER AND DRAINING THE BLADDER THROUGH THE DRAINAGE TUBE INTO A DRAINAGE BAG IN WHICH THE URINE IS COLLECTED WITHOUT DISCONNECTING AND RECONNECTING THE DRAINAGE TUBE FROM THE CATHETER ADAPTER SHAFT AND WITHOUT THE NECESSITY OF CLAMPING OFF THE DRAINAGE TUBE BETWEEN THE VALVE AND THE BAG; 3. A ONE WAY BALL VALVE AND HOUSING THEREFOR AT THE END OF THE DRAINAGE TUBE LOCATED WITHIN THE DRAINAGE BAG TO PREVENT REFLUX WHILE PERMITTING FREE FLOW OF URINE THROUGH THE DRAINAGE TUBE INTO THE BAG; 4. A PROTECTIVE CAP OVER THE END OF THE DRAW OFF TUBE FOR DRAWING URINE FROM THE DRAINAGE BAG, SUCH CAP BEING EFFECTIVE TO PROTECT THE END OF THE DRAW OFF TUBE FROM CONTACT WITH CONTAMINATED OBJECTS; AND 5. A DISPOSABLE, PLASTIC SYRINGE IN WHICH THE STERILE IRRIGATING FLUID IS PREPACKAGED AND WHICH IS PARTICULARLY ADAPTED TO BE USED WITH THE AFORESAID IRRIGATION VALVE TO PERMIT IRRIGATION WITHOUT LEAKAGE.

United States Patent Ericson L431 I Oct. [5,4] CLOSED URINARY DRAINAGEAND Q'I I- Il lll&LIlI I QN IRRIGATION SYSTEM Argyle Catalogue,A.-S.'Aloe C0. rec d 1960 [72] Inventor: Richard E. Ericson, Keene, N.H.Primary Examiner chafles R Rosenbaum [73] Assignee: C.R. Bard Inc.,Murray Hill, NJ. A rn y-W. on Seward [22] Filed: Dec. 28, 1970 57 PP NOJ101,976 'Aclosed system, disposable, urinary drainage and ir- Relawd U 8Application Data rigation system having the following improvements: l. aflexible drainage tube of increased internal diame- [63]contmuauonm'pafl of ter, which is larger than the maximum internaldiame- 23, 1969, abandonedter at which a continuous column of urine willform in the tube when urine flows therethrough by gravity Ffll'elgllApplmatloll pl'lol'lty Data from the bladder, to thereby preventmicroorganisms July 2 1970 Canada 087040 from ascending the tube thebladder; July 3, 1970 Great Britain ..32,372/70 2. a circumferentialslit extending part way around the circumference of the drainage tubelocated over the [52 US. Cl ..12s/275 Shank of the catheter adapter toProvide a unique yp [51 lm. Cl. ..A61f 5/44 im'gation valve foralternately irrigating the bladder [58 Field of Search ..128/214 227275-278 and draining the bladder thwugh the drainage tube into adrainage bag in which the urine is collected without disconnecting andreconnecting the drainage 56 R f CM tube from the catheter adapter shaftand without the 1 e erences I necessity of clamping off the drainagetube between UNlTED STATES PATENTS the valve and the bag;

3. a one way ball valve and housing therefor at the end g g of thedrainage tube located within the drainage bag e e s to prevent refluxwhile permitting free flow of urine 3,186,410 6/1965 Buono 128/275through the flrainage tube into the g 3,262,448 7/l966 Ring et al...l28/2l4.4 4. a protective cap over the end of t e draw off tube3,375,828 4/1968 Sheridan ..i28/35l for drawing urine from the drainagebag, such cap 3,416,567 12/ 1968 Von Dardel et al. .L....l28/2l4 beingefiective to protect the end of the draw off tube 3,421 ,509 1 [1969Fiore 128/349 from with contaminated Objects; and

Pannier, .II'. ...I28/2I4.4 5 a disposable yringe in the sterile i3,473,532 10/ i969 Eisenberg 1 28/295 igating fluid i5 prepackaged andwhigh is particularly 3,513,849 Vaillancourt et al ..l28/349 adapted tobe used with the aforesaid irrigation valve to permit irrigation withoutleakage.

41 Claims, 28 Drawing Figures PATENTEDnm 24 m2 SHEET 1 0F 8 INVENTOR-RICHARD E. ERICSON ATTORNEYS PATENTED 0m 24 1912 SHEET 2 BF 8 iNvENTOR'RICHARD E. ERICSON imfilh ATTORNEYS PATENTEDHBI 24 9 3 6 99 9 64 sum 3or 8 IN TOR RICHARD E. CSON ATTORNEYS PATENTED um 24 I972 SHEET N [If 8INVENTOR RICHARD E. ERICSON 0 by I" 1 ATTORNEYS PATENTED IT 24 1973 3699,964

SHEET 6 IF 8 I .90 I 1 I 205 II 202 1 68 INVENTOR,

I RICHARD E. ERICSON l W BY i, $9162., Manama ATTORNEYS PATENTEU BT I972SHEET 7 BF 8 INVENTOR. I BY RICHARD E. ERI CSON 98/362 wowgadomfi $10MATTORNEYS PATENTEDHBT 24 I97? 3 6 99 .964

SHEET 8 0r 8 INVENTOR. RICHARD E. ERICSON ATTORNEYS CLOSED URINARYDRAINAGE AND IRRIGATION SYSTEM CROSS REFERENCES TO RELATED APPLICATIONSthe closed urinary drainage and irrigation system disclosed and shown inmy copending U.S. patent application Ser. No. 669,183, filed Sept. 20,1967, now U.S. Pat. No. 3,478,743,Nov. 18, 1969.

SUMMARY OF THE INVENTION The invention relates to the aforesaidimprovements in drainage and irrigation systems, all designed to reducethe danger of retrograde infection of the urinary tract and bladder andsome of which are also designed to facilitate alternating irrigation anddrainage without leakage and with minimum chance of contamination.

A serious problem in urinary drainage, which involves draining the urinefrom the bladder into a urine collection bag or other container througha catheter and drainage tube attached by an adapter to the catheter, isthe ascent of microorganisms from the bag up the drainage tube to theurethra and bladder. It has been discovered that one reason for this isbecause the urine often forms a continuous liquid column in the drainagetube up which the microorganisms can ascend to the catheter by swimmingup the column or by being carried up the column by air bubbles.

According y, a primary object of the present invention is the solutionof this problem by eliminating the aforesaid ascent of themicroorganisms.

This is achieved in accordance with the present invention by enlargingthe internal diameter of the drainage tube, to a diameter which isgreater thanthe maximum diameter at which a continuous column of 0 urinecan be formed during urine flow in the tube by gravity from thecatheter.

Furthermore, by eliminating the formation of a continuous column ofurine in the drainage tube, the gravity flow of the urine can be readilyobserved through the transparent or translucent plastic tube to betterob serve patient output.

Also, the formation of a continuous column of liquid in the drainagetubing presents problems in making accurate periodic urine outputdeterminations with conventional drainage tubing, because it isimpossible to determine at any time that a measurement is taken how muchof the urine is being held up in the drainage tube. The enlargedinternal diameter drainage tubing of the present invention eliminatesthis disadvantage.

The inside diameter of standard drainage tubing is between sixthirty-seconds inch and nine thirty-seconds inch. The internal diameterof the drainage tube of the present invention is substantially greaterthan nine thirty-seconds inch and is preferably between eleventhirty-seconds inch and twelve thirty-seconds inch, the most preferreddimension being eleven thirty-seconds inch.

This aspect of the invention is based upon the recognition that if theinternal diameter of the tubing is increased sufficiently, a point willbe reached at which the formation of a liquid meniscus, which involves asurface tension phenomenon, is eliminated. Such a meniscus is formed bymolecules of the liquid forming a bridge between the drainage tubewalls. It is this meniscus which results in the formation of acontinuous urine column in standard drainage tubing. If the oppositewalls of the tubing are sufficiently far apart, cannot be formed at thenormal flow rate of the urine by gravity through the catheter andadapter a meniscus cannot be formed. Accordingly, a continuous urinecolumn cannot be formed.

Further advantages are achieved by making the plastic drainage tubehighly flexible. To achieve this, the plastic is made softer and thicker(greater wall thickness) than in conventional drainage tubes. A

preferred plastic is a highly plasticized polyvinylchloride, e.g.,plasticized with a phthalate plasticizer. Preferably, the plastic has asoftness falling within the Durometer-Shore A range, a preferredsoftness being between 60 and Durometer-Shore A, and the thickness ofthe wall of the drainage tube is substantially greater than 0.040 inch,for example 0.055 inch. The thickness of the wall of standard drainagetubes is between 0.030 inch and 0.040 inch.

This increased softness and increased wall thickness of the drainagetube permits it to take sharp bends without occlusions, which are apt toprevent drainage or to cause the formation of a continuous column ofurine even with the larger internal diameter drainage tubing.

Another problem with closed drainage and irrigation systems is that inorder to connect the irrigation source with the in-dwelling catheter toalternately introduce irrigation liquid into the bladder, it isnecessary to disconnect the end of the drainage tube, i.e., the catheteradapter, from the in-dwelling catheter. Upon disconnection of thedrainage tube from the catheter, it is difiicult for the nurse or doctorto continue to hold it while irrigating. Consequently, it is usuallyplaced upon the bed or upon a table and, in many cases, becomescontaminated. Furthermore, it is apt to fall on the floor to furtherincrease the chances of contamination. Also, in disconnecting andreconnecting the drainage tube with the in-dwelling catheter, thefingers are very apt to come in contact with the end of the drainagetube or with the open end of the catheter funnel with resultingcontamination. When it is remembered that during irrigation, thisdisconnection and reconnection is repeated alternately a number oftimes, it will be realized that the chances of contamination areextremely great.

In an attempt to overcome these very serious disadvantages of theaforesaid conventional disconnectreconnect arrangement, in my aforesaidcopending application, I propose a catheter with a branch having a valvein it, which normally closes the branch during drainage but which can beforced open by inserting the tip of an irrigation syringe or of anirrigation adapter connected to an irrigation bottle by tubing. Althoughthis avoids many of the disadvantages of a disconnectreconnectarrangement, it has further disadvantages as follows:

1. in order for the insertion of the tip of the syringe or adapter toopen the branch valve while, at the same time, forming a seal with thebranch to prevent leakage,

construction cannot be used with the many different commerciallyavailable tip designs, which is essential as a practical matter;

2. when the irrigation tip is inserted into the branch to open thevalve, it tends to push contaminants, which accumulate at the valve,into the catheter and eventually into the urethra and bladder withdanger of infection; upon repeated irrigations, the build up ofcontaminants on the inside and the outside of the valve increases withconsequent'increased chance of infection, due to the lack of any selfcleaning of these areas; furthermore, with such a construction, thereare undercut pockets and recesses in which contaminants can easilycollect; this is a disadvantage with any kind of valved irrigationbranch;

3. the cross-sectional area of the portal entry is restricted by thevalve construction so that blood clots and debris from the bladder andurethra are apt to plug the valve; even if they do not plug the valve,they are a source of contamination and interfere with good and properirrigation;

4. the branch and valve contained therein add to the bulk, unbalance andinstability of the catheter and drainage tube assembly and are apt todig into the patient when he rolls over, all of which add to thediscomfort of the patient;

5. with a valved branch or side arm, the drainage tube must be shut offduring irrigation to prevent the irrigating fluid from flowing throughthe drainage tube into the drainage bag; this must be done by clampingthe drainage tube; however, most hospitals will not approve of clampingthe drainage tube in this manner because of the danger that the nursemight forget to unclamp the tube after the irrigation step is terminatedand drainage is commenced; although this can be avoided by the use ofcomplex one-way check valves,- these are so complicated they areimpractical;

6. it is not possible to take a urine specimen directly from thecatheter without disconnecting the drainage tube from the catheter.

Accordingly, it is another object of the present invention to provide acombined drainage and irrigating system in which the aforesaiddisadvantages of a connect-disconnect arrangement and a valved branchare avoided.

This is achieved in accordance with the invention by providing anormally closed entry in the side of the drainage tube into which thesyringe tip or irrigation adapter can be inserted to thereby providecommunication between the irrigation source and the catheter whileshutting off communication between the catheter and the drainage bagwithout disconnecting the drainage tube from the catheter. It isachieved in accordance with a preferred embodiment of the invention byproviding a circumferential slit extending part way around thecircumference of the drainage tube located over the shank of thecatheter adapter with the unslit portion of such circumference acting asa flexible hinge about which the slit end of the tube can be flexed offthe open end of the adapter shaft to expose it for irrigation byinserting into it the externally tapered tip of an irrigation syringe oran externally tapered irrigation adapter connected to a source ofirrigating fluid. A

I sleeve is provided over the slit portion of the drainage tube toprevent accidental opening of the slit and also to protect againstcontamination of the slit.

The catheter adapter is preferably made of a material, preferablyplastic, which has greater resilience and flexibility and is lessbrittle than conventional plastic catheter adapters so that when theexternally tapered irrigation syringe tip or externally taperedirrigation adapter is inserted into the open end of the adapter shankand into engagement with such open end an excellent seal is formedbetween such open end and the tip or irrigation adapter without dangerof cracking the catheter adapter with most tips and adapters ofconventional design.

After irrigation, it is necessary only to flex the slit end of thedrainage tubing about the aforesaid flexible hinge and back over theopen end of the catheter adapter shaft followed by sliding theprotective sleeve in place over the slit portion of the tube.

During irrigation, the slit end of the tube which has been removed fromover the catheter adapter shank is held in place by the hinge portion tothereby reduce the danger of contamination thereof, as compared to theaforesaid connect-disconnect arrangement.

With this kind of an arrangement the dangers of touching either the slitend of the sleeve which is flexed off the catheter adapter shank or theopen end of the catheter adapter shank are greatly reduced.

Furthermore, this arrangement provides a self cleaning effect, ascompared to a valved irrigation branch, in that any contaminants whichmight accumulate on the aforesaid slit end of the tube or at theaforesaid open end of the catheter adapter shank during irrigation willbe washed down the enlarged drainage tube into the drainage bag afterthe slit end of the tube has been again flexed back onto the catheteradapter shank and drainage is commenced.

Because when the irrigation tip or adapter is introduced into theexposed end of the catheter adapter shank the drainage tube is cut offfrom communication with either the source of irrigating fluid or thecatheter, it is not necessary to clamp the drainage tube duringirrigation, as is true with the use of a valved irrigation branch.

Furthermore, this slit tube arrangement is ultra simple, inexpensive,fool-proof and avoids the necessity of a bulky and uncomfortable valvedirrigation branch.

Another problem which presents itself with these types of drainagesystems is the danger of reflux of urine from the collection bag backthrough the drainage tube to the urethra. In the past it has beenattempted to avoid this by applying to the end of the drainage tubewhich extends into the drainage bag a flutter valve made up of two flatpieces of flexible material, which are normally collapsed against eachother to prevent flow of fluid into the tube but which are forced apartby the flow of urine from the catheter through the tube into the bag.Although this flutter type valve is effective to prevent reflux, thepressure necessary to open it is usually such that it sometimes tends tosupport a column of urine.

Accordingly, it is yet another object of the present invention toprovide an improved valve arrangement at the end of the drainage tubewithin the drainage bag which does not have the aforesaid characteristicof a flutter valve.

This is achieved by means of a ball valve made up of (a) a housing, oneend of which is secured to the end of the drainage tube and has a valveseat and the other end of which is provided with a stop and (b) a ballwhich is adapted to roll freely within the housing to a closed positionagainst the valve seat and to an open position against the stop. Theball is instantaneously moved to the closed position at the commencementof any flow from the bag into the housing to instantaneously seat on thevalve seat and thereby prevent reflux of urine into the drainage tube.Furthermore, the ball is instantaneously responsive to any tilting ofthe bag to close the valve seat. On the other hand, it is highlyresponsive to even a very slight flow of urine in the drainage tube tothe valve seat to instantaneously roll to its open position against theaforesaid stop to allow free flow of the urine through the housing intothe bag without any build up of a urine column in the drainage tube.

By making the minimum open cross-sectional flow area into, through andout of the housing greater than the maximum cross-sectional area of thedrainage tubing at which a continuous column of urine is formed in thetubing, this insures against the build up of such a column due torestriction of urine flow.

Since the housing is made of a plastic which is substantially more rigidthan the bag, it effectively prevents the bag panels from stickingtogether at the exit end of the drainage tube to thereby impede the flowof urine from the drainage tube into the bag, which may also be a causeof build up of a continuous liquid column in the drainage tube.

Furthermore, the housing prevents the inner surfaces of the bag panels,if contaminated, from coming in contact with the end of the enlargeddrainage tube.

Preferably, a plurality of slots are provided in the housing for flowbetween the housing and bag and they are elongated and extend in thelongitudinal direction of the housing. In this way, free flow isinsured. Furthermore, the ball must be of a material which has a greaterspecific gravity than the urine and which is resistant to attack byurine, a preferred material being stainless steel. This is to preventthe ball from floating in urine insidethe housing and from corroding.

Another pr-oblem which, in some instances, has presented itself with theclosed drainage system disclosed in my aforesaid copending patentapplication is the contamination of the end of the draw-off tubing fordrawing urine out of the bag. Such draw-off tubing, as well as thedraw-off tubing of conventional urinary drainage systems, is apt tobecome contaminated by contact with the fingers or with contaminatedobjects in the room.

Accordingly, it is yet another object of the present invention toovercome this problem.

This is achieved by providing a protective cap over v and around the endof the draw-off tubing. The cap comprises a housing into which the endof the draw-off tubing extends but which extends axially beyond such endof the draw-off tubing with the inner surface of the housing around theend of the draw-off tubing being substantially larger in radius than theouter surface of the end of the draw-off tubing, whereby the innersurface of the housing is spaced radially and outwardly from the outersurface of the end of the draw-off tubing located within the housing. inthis way, the housing at all times protects the end of the draw-offtubing to prevent it from becoming contaminated.

Furthermore, when this cap is used with the closed drainage systemdisclosed in my aforesaid copending application, which has a relativelyrigid stabilizing tube extending along the top of the bag, it has thefurther advantage that when the end of the draw-off tubing is insertedinto an open end of the stabilizing tube when the tubing is not beingused, as described in the aforesaid such end of the stabilizing tube isreceived within the housing between the housing wall and the end of thedraw-off tubing to provide a seal between the stabilizing tube and thedraw-off tubing.

Preferably, the protective cap is provided with an integral internalhollow tubular section, which is an extension of and functionally formsthe end portion of the draw-off tubing and it is this end portion whichis located within the housing and is spaced radially and inwardly fromthe housing wall, as aforesaid. Preferably, the external surface of theaforesaid tubular section is tapered to facilitate insertion thereofinto the end of the stabilizing tube and to provide a tight sealing fitbetween such section and the stabilizing tube. The protective capinsures against the clamp on the drawoff tubing accidentally sliding offthe end thereof.

Conventionally, irrigation with an irrigation syringe is carried outwith the use of the irrigating syringe, a basin and a bottle containingthe irrigating fluid. The irrigating fluid is poured into the basin andis aspirated into the bulb or piston type syringe followed by irrigationof the patient. This technique has the serious disadvantages that it istime consuming, it involves a number of manipulations and it is subjectto a number of errors. In pouring the irrigating fluid from the bottleinto the basin and in aspirating it from the basin into the syringe,there are multiple opportunities for contamination.

Accordingly, it is yet another object of the invention to provide anirrigating syringe and technique which will avoid these disadvantages.

This is achieved in accordance with the present invention by providing aprepackaged, plastic irrigating syringe, containing the sterileirrigating fluid, such as a saline solution, prepackaged and sealedtherein. Thus, the syringe functions not only as a bulb type syringe butalso as a package for the irrigating fluid. This syringe is made of aheat resistant, compressible, flexible, transparent or translucent,resilient, plastic material having a low rate of moisture vaportransmission, which is highly resistant to autoclaving conditions,particularly, heat and hot steam, and which has a reduced neck extendingaxially from an end thereof into an externally tapered elongated syringetip. The tip has a cap removably secured thereover and therearound witha sealing surface of the cap urged against a complimentary sealingsurface of the tip to seal the syringe. After the cap has been removedand the tip has been inserted into the exposed open end of the cathetershank, as aforesaid, the fluid can be forced out of the bottle bysqueezing and compressing the side walls, aspiration into and out of thebladder being achieved by alternate and repetitive compression andrelease.

Preferably, the bottle is made of a copolymer of a major proportion ofpropylene and a minor proportion of ethylene and is of a size which willfit in the palm of the hand with the preferred maximum and minimum wallthickness, exclusive of the tip, being 0.035 inch and 0.020 inch,respectively.

The use of this prepackaged syringe reduces to a minimum the danger ofcontamination and the number of procedural steps required forirrigation. Also, the syringe is disposable so that once it is emptied,it is discarded with no danger of contamination due to repeated use.

Preferably, the bottle-syringe has a relatively flat or equivalentbottom so that it can be placed upright on a supporting surface withoutdanger of spillage or tip contamination.Preferably, it is in the form ofa cylinder with the tip extending from one end of the cylinder.

Further advantages and features of the invention will be apparent fromthe following description and accompanying drawings describing andshowing preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS drainage bag(this is the normal position of the draw-off tubing) and in broken linesduring draw off;

FIG. 2 is a section taken along the line 2--2 of FIG. 1;

FIG. 3 is a section taken along the line 3-3 of FIG.

FIG. 4 is an enlarged view in perspective with portions cut away of thecatheter adapter and the end portion of the urinary drainage tubesecured thereto of the system of FIG. 1, showing the irrigation slit foralternate irrigation and drainage and with the protective sleeve locatedover the irrigation slit to protect the slit and to prevent it frombeing opened;

FIG. 5 is a non-sectional view like FIG. 4 but with the protectivesleeve slid back on the drainage tube to expose the irrigation slit;

FIG. 5A is a view like FIG. 5 in which the irrigation slit lies in aplane at an angle of about 45 to the longitudinal center line of thedrainage tube rather than in a plane 90 to such center line as in FIG.5.

FIG. 6 is a view in perspective of the irrigation arrangement of FIGS. 4and- 5 with the protective sleeve slid off from the slit in the drainagetube to expose it and with the slit end of the drainage tube swung offfrom the open end of the catheter adapter shank to expose such open endfor taking a sample of urine and/or for irrigation;

FIG. 6A is a view corresponding to FIG. 6 of the embodiment of FIG. 5A;

FIG. 6B is a side view of the embodiment of FIG. 5A;

FIG. 7 is a view like FIG. 6 showing the tip of an irrigation syringeinserted into the open end of the exposed catheter adapter shank endduring irrigation;

FIG. 8 is a view taken along the line 8-8 of FIG. 7;

FIG. 8A is a reduced view of the irrigation arrangement of FIG. 7 withthe open end of the catheter adapter shank exposed for irrigation butshowing irrigation from a bottle of irrigating fluid through anirrigating tube and tapered adapter rather than from a syringe;

FIG. 9 is a section taken along the line 9-9 of FIG.

FIG. 10 is a section taken along the line 10-10 of FIG. 9;

FIG. 11 is a view like FIG. 9 showing a different construction forholding the protective sleeve in place over the slit drainage tube;

FIG. 12 is an enlarged view in perspective of the end of the drainagetube of FIG. 1 which extends into the drainage bag and with a part ofthe bag panel cut away to expose the ball valve located at such end ofthe drainage tube;

FIG. 13 is a section taken along the line 1313 of FIG. 12;

FIG. 14 is a section taken along the line 14-14 of FIG. 13;

FIG. 15 is a view in perspective of the free end of the draw-off tube ofFIG. 1 together with a portion of the comer of the drainage bag andshowing the protective cap over such end of the draw-off tube and thedraw-off tube removed from the stabilizing tube extending along the topof the drainage bag;

FIG. 16 is a view in elevation and partially in section of the part ofthe closed drainage system shown in FIG. 15;

FIG. 17 is a section taken along the line 17l7 of FIG. 16;

FIG. 18 is a view partially in section of the prepackaged irrigationsyringe shown in FIGS. 7 and 8;

FIG. 19 is a view in perspective of another kind of irrigating entryassociated with the catheter adapter and showing the closure therefor insolid lines in open position and in broken lines in closed position;

FIG. 20 is a view like FIG. 19 with the closure open and with the tip ofthe irrigating syringe of FIGS. 7 and 8 inserted in the irrigating entryfor irrigation;

FIG. 21 is a longitudinal view in cross-section of the embodiment shownin FIG. 20, with the closure shown in full lines in the open positionand in broken lines in closed position;

FIG. 22 is a view taken along the section line 2222 in FIG. 21 with theirrigating syringe removed;

FIG. 23 is a sectional view in elevation of another kind of irrigatingentry in the catheter adapter utilizing a flap valve shown in its normalposition during drainage; and

FIG. 24 is a view like FIG. 23 during irrigation with the protective capremoved and with the tip of the syringe introduced into the irrigatingentry to shut off communication between the catheter and the drainagetube.

DETAILED DESCRIPTION With reference to the figures, the numeral 2represents a closed urinary drainage and irrigation system comprising asealed, plastic urinary drainage bag 4, a urinary drainage tube 6, anend of which extends into the interior of bag 4 and the opposite end ofwhich is provided with a catheter adapter 8, and a draw-off tube 10extending from the bottom of the bag 4 and having a clamp 11.

The urinary drainage bag 4 is of generally the same construction as thatdisclosed in my copending patent application Ser. No. 669,183 now US.Pat. No. 3,748,743. It comprises a pair of thin, flat, flexible,plastic, e.g., polyvinylchloride, sheet panels 12 and 14 arrangedback-to-back against each other and heat sealed together along theirmargins at 16 to form a flat, collapsible bag having an upper edge 18, alower edge 20 and two side edges 22 and 24. Preferably, the front panel12 is transparent or translucent whereas the rear panel 14 is opaque andwhite, and the inside surface of each of the panels is embossed with amedium tafi'eta finish to thereby make the surface rough to reduce thetendency of the panels to adhere against. each other. A pair of heatseal lines 26 and 28, extending along but spaced from the upper edge 18of {the bag, separate the bag into a main urine collectionichamber 30and an upper marginal pocket 32 extending along the top of the bag fromside-to-side. The pocket 32 is open at its ends 34 and 36, the sideedges 22 and 24 not being sealed in these areas.

Located slightlyabove the seal line 28 are a plurality of horizontallyspaced, horizontal slits 38 heat sealed along their edges and extendingthrough both panels of the bag for receiving a flexible plastic hangingstrap 40 for hanging the bag to a bed rail or the like during use, allas described in the aforesaid copending application.

Snugly but removably received in the pocket 32 above slits 38 (the endportion 27 of line 26 and the branch 29 of line 28 form restrictions inthe pocket) is a cylindrical, elongated, stabilizing tube 42 made ofplastic, e.g., polystyrene, and open at both ends 44 and 46. The plasticof tube 42, and hence tube 42, are relatively rigid compared to theplastic bag 2. The length of the plastic, stabilizing tube 42 is aboutthe same as the overall width of the bag proper from side to side.However, the unsealed edge 34 of the pocket 32 terminates short of thecorresponding main side edge 22 of the bag, as shown, so that thestabilizing tube 42 protrudes beyond the edge 34 of the pocket, asshown, for receiving a protective cap 48 secured to the free end of thedraw off tube 10, as shown. The fit between the stabilizing tube 42 andthe restrictions 27 and 29 of the pocket 32 is a snug one to insureagainst the tube 42 accidentally sliding out of an open end of thepocket 32.

The lower edge 20 of the bag bows downwardly as shown, the lowest area21 lying near the middle of the lower edge 20 directly below the middleslit 38.

Located in the stabilizing tube 42, opposite the end which receives theprotective cap 48 of the draw-off tube is a filter 50, e.g., a wad ofcotton, for filtering out microorganisms from any air which might enterthe urine collection chamber 30 through the stabilizing tube 42 and thedraw-off tube 10, the free end of which is removably received in the end46 of the stabilizing tube 42 in an air-tight manner to providecommunication therebetween, as will be described more fully hereinafter.

Although the open-ended stabilizing tube 42, and draw-off tube 10provide communication between-the atmosphere and the fluid chamber 30through the filter 50 for gas sterilization of the system and forover-flow from the bag 2, nevertheless, the wad 50 prevents-the entry ofmicroorganisms into the system, all as described in my aforesaidcopending patent application.

The hanging strap 40 is of a highly flexible, plastic, e.g., linearpolyethylene and has the same shape and the same fastening button 41 forremovably and adjustably fastening the ends together as thecorresponding hanging strap described in the aforesaid pending patentapplication.

The relatively rigid stabilizing tube 42 stabilizes the bag so that itcan be hung by the single strap 40 without sagging or wrinkling due tothe unbalanced weight of the bag. Furthermore, it provides support forstrap suspension by the strap 40 and the end 46 thereof provides aprotective and convenient receptacle for the free end of the draw-offtube 10. Also the draw-off tube, when located within the end 46 of thestabilizing tube 42, as shown in FIG. 1, provides a route for gassterilizing the system and for overflow in the event that the bagbecomes too full and before the bladder becomes distended in theeventthat the bag is not emptied when it should be, all as described inmy copending patent application.

The end portion of the soft, flexible, transparent or translucentplastic, e.g., polyvinylchloride, drainage tube 6 extends through theupper left side edge 24 of the bag at the thickened seal area 52 intothe fluid chamber 30 in an air-right manner, as shown. Actually, theedge portions of the panels 12 and 14 at the seal area 52 arehermetically sealed around the periphery of and to a short plasticreceptor tube (not shown) through which the drainage tube 6 extends andin which it is hermetically sealed. The end portion 64 of the drainagetube 6 which is located within the drainage bag 4 is provided at its endwith a ball valve construction 66, shown in detail in FIGS. 12 to 14 andwhich will be described more fully hereinafter. The other end ofdrainage tube 6 is fitted tightly around the shank 54 (FIGS. 4 and 5) ofthe catheter adapter 8 in an air-tight manner and is provided with anirrigation entry arrangement 56 to be described in detail hereinafter.

The catheter adapter is covered by a conventional, removable, flexible,plastic (polyethylene) adapter cap (not shown) which snaps over theshoulder 57 in an airtight manner but which is removed when the systemis to be used so that the rubber catheter 58 (Foley catheter in thedrawings) can be attached thereto, as shown in FIGS. 4 and 6-8.

The end portion of the soft, flexible, transparent or translucent,plastic (e.g. polyvinylchloride) draw-off tube 10 extends in anair-tight manner between the panels 12 and 14 through the lower sideedge 22 at the enlarged seal area 60 of the bag into the fluid chamber30. Actually, as in the case of the drainage tube 6, the draw-off tube10 is hermetically sealed by solvent cement within a flexible, plastic(polyvinylchloride), transparent receptor tube (not shown) which extendsthrough the sea] area 60 with the adjacent edge portions of the panels12 and 14 being hermetically sealed by heat around and to the peripheryof the receptor tube at the seal area 60. The other end 62 (FIGS. 15-17)of draw-off tube 10 is beveled and is secured within the protective cap48, which is removably applied over the end 46 of the stabilizing tube42, as shown in FIG. 16, and which will be dewribed more fullyhereinafter.

The improvements provided by the present invention are directedprimarily to the irrigation entry arrangement 56, to the ball valveassembly 66, to the protective cap 48, to a drainage tube 6 of increasedinternal diameter, as will be described more fully hereinafter,

and to an improved prepackaged irrigation syringe 68 (FIGS. 7, 8 and 18)in which sterile irrigation fluid is prepackaged and which isparticularly adapted for use with the irrigation entry arrangement 56 asshown in FIGS. 7 and 8 and as will be described more fully hereinafter.The aforesaid improvements will now be described in detail as follows.

THE ENLARGED INSIDE DIAMETER DRAINAGE TUBE 6 The inside diameter of thedrainage tube 6 leading from the catheter adapter 8 to the drainage bag4 is made large enough so that urine will pass by gravity from thecatheter adapter through the tube and into the bag without forming acontinuous column of urine.

therein, i.e., the internal diameter and cross-sectional area,respectively, of the drainage tube 6 are greater than the maximuminternal diameter and cross-sectional area, respectively, at which acontinuous column of urine will form in the tube 6 when urine flowstherethrough from the catheter adapter by gravity.

In conventional drainage tubes, having a standard inside diameterbetween six thirty-seconds inch and nine thirty-seconds inch, the urineflowing by gravity from the catheter adapter through the tube into thedrainage bag may form a continuous column of urine in the tube fromdrainage bag to catheter, up which column microorganisms may ascent tothe catheter S8 and thence to the urethra by swimming up the column orby being carried up the column by air bubbles.

The formation of such a continuous urine column in the drainage tube isavoided.

This by increasing the internal diameter of the drainage tube 6sufficiently to eliminate the formation of a liquid meniscus in the tubewhich involves a surface tension phenomenon as previously explained.

Urine has components which giveit adhesive characteristics andconsequently the surface tension phenomenon is greater than with waterso that a solid column of liquid forms more easily.

It has been found that the minimum inside diameter to prevent theformation of a urine meniscus and thereby eliminate the aforesaidsurface tension phenomenon, which causes the formation of a continuousurine column, is a diameter substantially greater than ninethirty-seconds inch. Therefore, the minimum inside diameter issubstantially greater than nine thirtyseconds inch and the preferred ID.is between eleven thirty-seconds inch and twelve thirty-seconds inch. Ifthe inside diameter is made too large the tubing becomes too cumbersome.

Because a solid column of urine does not form in the enlarged tube 6,the free flowing movement of the urine through the tube can be easilyobserved, which is an important advantage in observing rate of flow ofurine.

The tube 6 is preferably made highly flexible so that it can takerelatively short bends without forming occlusions or restrictions whichcause the build up of a continuous urine column. To achieve this, it ismade somewhat softer and thicker (wall thickness) thanconventionaldrainage tubes. The tube 6 shown in the drawings is made of plasticizedpolyvinyl chloride, the plasticizer being a phthalate ester, e.g.,diisooctyl phthalate.

The thickness of the wall of the drainage tube 6 in they drawings is0.055 inch, whereas the thickness of the wall of standard drainage tubesis between 0.030 and 0.040 inch. The thickness of the wall of thedrainage tube of the instant invention is preferably substantiallygreater than 0.040 inch.

The tubing 6 preferably has a softness falling within Durometer-Shore A.More preferably, the softness is between 55 and 80 (Durometer-Shore A).Tubing 6 in the drawings has a Durometer-Shore A softness of 65.

IRRIGATION ENTRY ARRANGEMENT 56 The end portion (FIGS. 4-10) of theinternally enlarged flexible drainage tube 6 is fitted tightly over andaround the hollow shank 54 of the catheter adapter 8 with a friction fitand has a circumferential slit 72 which extends around a major part of,but not entirely around, its circumference and which is located over theshank. This slit end portion 70 of tube 6 is normally covered by aplastic, e.g., polyethylene, protective irrigation sleeve 74 which, likeadapter shank 54, is relatively rigid compared to tube 6, which isfitted snugly but slidably around such end portion 70 and whichprotrudes axially beyond the open end 76 of adapter shank 54 over aportion of the tube 6 located adjacent to, but not over, such shank asshown in FIG. 4.

When the relatively rigid irrigation sleeve 74 is positioned over theslit tube portion 70, as shown in FIG. 4, to cover and close slit 72,the end portion thereof over the shank 54 is received with a snugfriction flt within the skirt 78, which extends integrally from theperiphery of shank 54 radially outwardly and then longitudinally alongthe shank 54, as shown in FIG. 4. The friction fit between the skirt 78and the end 75 of irrigation sleeve 74 prevents the sleeve 74 from beingaccidentally moved axially off the slit portion 70 of tube 6 to therebyaccidentally expose the slit.

The radially extending portion 79 of skirt 78 is spaced a slightdistance from the shoulder 57 of the adapter 8, as shown, in order toprovide an annular external radiused recess 81 for receiving the end 84aof the adapter-receiving funnel 94 of rubber catheter 58, which isstretched around the shoulder 57 to hold the catheter 58 firmly on theadapter 8, as shown in FIGS. 4 and 8. The external comer 83 of the skirt78 is radiused.

The circumferential slit 72 is exposed by sliding the protective sleeve74 axially along the tubing and off from the shank 54 so that the endthereof clears the open end 76 of such shank, as shown in FIG. 5.

Irrigation sleeve 74 has two oppositely disposed corrugated fingerpieces 82 to aid in sliding the sleeve along tube 6 off the slit portion70 of the tube to expose the slit.

Although the friction fit between skirt 78 and the end portion 75 of thesleeve is tight enough to prevent accidental sliding of the sleeve offthe slit portion 70 to expose the slit, it is not so tight as to undulyhinder such movement of the sleeve deliberately with the fingers fromthe slit covering position shown in FIG. 4 to the slit exposing positionshown in FIG. 5 and back again. Also, although the fit between thesleeve and the end portion 70 of the tube 6 is snug, it is not so tightas to unduly hinder the aforesaid movement of the sleeve.

As aforesaid, the slit 72 extends around only a part of thecircumference of the end portion 70 of tubing 6. The remaining unslitpart 73 of such circumference acts as a flexible, resilient hinge forswinging the slit end 84 of the tube 70 off the open end 76 of theadapter shank 54 to thereby expose such open end 76, as shown in FIG. 6,for irrigating the bladder, as shown in FIGS. 7 and 8, by inserting thetapered neck 90 of the flexible and resilient plastic irrigation syringebottle 68, filled with sterile irrigation fluid, into the exposed openend 76 of the shank and squeezing the irrigating fluid into the bladderthrough the catheter.

When irrigation is completed the tapered neck 80 is removed from theopen exposed end 76 of shank 54 and the slit end 84 of the tube 6 isswung about the unslit hinge portion 73 of the tube circumference backover the open end 76 of the shank again into abutting relation with theother opposed slit end 91 of the tube, whereupon the protective sleeve74 is slid axially back over the slit end portion 70 of the tubing 6(over the slit 72) and over the adapter shank 54 to the position shownin FIG. 4 with the edge portion 75 thereof snugly received within theskirt 78.

The rigid protective sleeve 74 prevents accidental swinging of the slitend 84 off the open end 76 of the shank 54 of the adapter. Also, itprotects the slit 72 from contamination and holds the slit ends of thetube snugly together, i.e., it prevents any parting of such slit ends.

The length of the relatively rigid sleeve 74 is such that when it is inthe close position shown in FIG. 4, it extends away from the catheter asufficient distance beyond the slit 72 and the open end 76 of the shank54 so that flexing of the tube 6 will not disturb the slit, i.e., itisolates the slit from such flexing. The relatively rigid adapter shank,which functions as a rigid support for the slitted portion 70 of thetube, cooperates to so isolate the slit.

The slit 72 is located over the shank 54 close enough to the open end 76of the shank to permit the slit end 84 of the tube '70 to clear suchopen end 76 when such slit end is swung about hinge 73 to the irrigationposition shown in FIGS. 6-8 to expose such open end 76 for irrigation. x

The outside diameter of he adapter shank 54 is larger than the normalinside diameter of the drainage tube 6 to achieve a tight, liquid andair-proof seal between'the slit end 70 of the tube and the adapter shankwhen the sleeve 74 is in the close position shown in FIG. 4. However,the fit is not so tight that the slit end 84 of the tube 70 cannot beeasily swung over the open end 76 of the catheter shank to the positionshown in FIG. 6.

The sleeve 74 and slit end portion 70 of tube 6 are in the positionsshown in FIG. 4 during drainage. The tight fit between the slitted tubeend portion 70 and the shank 54 of the adapter and the relatively snugfit between the irrigation sleeve 74 and the tube portion 70, togetherwith the fact that the slit ends of the tube 70 are held in snuglyabutting relationship on the shank 54, insures against leakage of urinethrough the slit and also reduce the danger of contamination enteringthe system through the slit. The prevention of a continuous column ofurine in the drainage tube because of the increased intemal size of suchtubing also prevents such leakage since the urine falls from the openend 76 of the adapter shank 54 into the tubing 6 beyond the slit 72 andconsequently does not have an opportunity to back up between the tubeend portion 70 and the periphery of the adapter shank 54.

It is noted that the end of tubing 6 abuts against the internal surfaceof the wall 79 of skirt 78. The same is true of the end of sleeve 74when it is in the close position shown in FIG. 4.

It is preferred to have the slit 72 in the end portion 70 of thedrainage tube 6 located around the relatively rigid catheter shank, asshown, but the slit 72 can be located further down the drainage tube 6toward the drainage bag. In such case, it is preferred to provide arelatively rigid inner sleeve fitted within such slitted portion of thetube with a tight friction fit to take the place of the adapter shank torigidly support such slit portion with the outer, relatively rigidprotective sleeve located over such slitted portion and the relativelyrigid inner sleeve. In such case, the inner sleeve may be of the samedimensions as the adapter shank 54 and the position of the slit relativeto the ends of such inner sleeve may be the same as the position of slit72 relative to the shank 54in FIG. 4. However, the closer the slit is tothe catheter adapter the better. If such a relatively rigid innersupporting sleeve is omitted, it is more difficult to isolate the slitfrom flexing of the tube 6, it is more difficult to prevent accidentalparting of the slit ends and leakage through, and contamination of, theslit is more apt to occur, but if the outer protective sleeve is madelong enough to effectively isolate the slit from flexing of the tube 6and to prevent accidental parting of the slit ends, and if it fitssnugly enough around the tubing to minimize leakage, such inner sleevecan be eliminated.

If desired, this same slit valve principle can be used on the catheteritself if inside and outside, relatively rigid sleeves are used.

A small piece of larger diameter, flexible plastic (polyvinylchloride)tubing 92 is sealed (by solvent or friction sealing) around the drainagetubing 6 at a point spaced from the slit 72 and from the open end 76 ofshank 54, as shown in FIGS. 4 and 5, to act as a stop for the protectivesleeve 74 when it is slid axially over the drainage tubing out from overthe slit to the position shown in FIG. 5.

The catheter adapter 8 is novel in that it is made of a resin, such aspolyvinylchloride, which has a greater resilience, flexibility andimpact strength and is substantially less hard and brittle thanconventional polystyrene catheter adapters, although it is stillrelatively rigid so that the shank 54 thereof provides an excellentnon-bending and non-yieldable support for the slit portion 70 of thetube 6. Accordingly, when the tapered neck or tip of the irrigatingsyringe 68 is thrust firmly into the open end 76 of the adapter shank54, an excellent liquid-tight seal is provided between the inner edge 93of such open end 76 and the tapered tip 90 so that irrigation can beachieved without leakage and without entry of contaminants into thesystem and without danger of breaking the shank. This greaterresilience, flexibility and yieldability of the adapter shank insures anexcellent liquid-tight seal with tapered irrigation tips of a variety ofsizes, including all conventional sizes.

The tapered neck 90 itself is made of a linear copolymer of ethylene andpropylene so that it also has resilience and flexibility to contributeto the liquid-tight seal between it an the open end 76 of the shank 54to thereby insure irrigation without leakage.

Since the protective sleeve 74 is also made of a plastic which, althoughrelatively rigid, also has suffrcient resilience and flexibility(preferably the same material as the catheter shank), a tight fit can beachieved between the end portion 75 thereof and the skirt 78 while stillpermitting the sleeve to be slid out of the skirt without difficulty.

As can be seen in FIG. 6, a urine sample can be conveniently obtained atany time with minimum danger of contamination merely by sliding theirrigation sleeve off the slitted portion 70 of the drainage tubefollowed by swinging the slit end 84 off the open end 76 of the catheteradapter shank 54, as shown in FIG. 6, while the catheter is in place inthe urethra and bladder of the patient, i.e., with an in-dwellingcatheter.

Although in the drawings the catheter is shown secured to the catheteradapter, the system is manufactured and shipped with a protective cap(not shown) secured over the catheter adapter in an air-tight manner toprovide a closed system. The cap is removed when the system is to beused and the catheter has been inserted into the patient, followed byinserting the adapter into the adapter receiving funnel 94 of thecatheter, as shown in FIGS. 4 and 6-8.

Since both the adapter 8 and the irrigation sleeve 74 are molded, closetolerances can be accurately achieved between the internal annularsurface of the skirt 78 and the external annular surface of the endportion 75 of such sleeve when the sleeve is located within the skirt inthe position shown in FIG. 4, to

thereby insure a good snug fit therebetween to prevent accidentalsliding movement of the sleeve to expose the slit 72 while permittingthe sleeve to be deliberately so moved by the fingers without difficultywhen so desired.

However, such skirt can be omitted as shown in FIG. 11, in which casethe snug fit between the internal surface of the sleeve 74 and theexternal surface of the slit tube portion 70 over the shank 54 is reliedon to prevent accidental sliding movement of the sleeve. Actually, insuch case the external diameter of the shank and the internal diameterof the sleeve are such as to squeeze the tube portion 70 between them toinsure the aforesaid snug fit between sleeve and tube. However, it isdifficult to control the tolerances of plastic tubing and consequentlythe fit between the sleeve and tubing over the shank may be too tight,in which case movement of the sleeve becomes too difficult, or the fitmay be too loose in which case the sleeve is apt to be accidentallymoved to expose the slit. Accordingly, the FIGS. 4l0 embodiment with theskirt 78 is preferred although the FIG. 11 embodiment has provedsuccessful also.

Irrigation can be carried out not only with the prepackaged irrigatingsyringe 68 shown in FIGS. 7 and 8 but also, with conventional irrigatingsyringes and, as shown in FIG. 8A, with a conventional supply 96 ofirrigating fluid in a stoppered bottle 98 having a vent tube 100 and aplastic, flexible, translucent or transparent irrigation tube 102 with amolded, plastic, e.g., polyvinyl chloride, adapter 104 secured at itsend, which is relatively rigid compared to the tube 102 and which isexternally tapered so that when it is inserted into the exposed open end76 of the adapter shank 54, as shown in FIG. 8A, the tapered peripheryforms a liquid-tight seal with such open end by engagement with theouter end 93 of the bore 55 in the adapter shank 54in the same way thatthe tapered neck of the syringe 68 forms a seal with such open end inFIG.

8. A clamp 106 is provided for the irrigating tube 102.

Although in FIGS. 1-5, 6 and 7-11, the circumferentially extendingirrigation slit 72 lies in a plane which is 90 to the longitudinalcenter axis of the irrigation tube, the circumferential slit may lie ina plane at any other angle to the longitudinal center axis of theirrigation tube, as shown in FIGS. 5A, 6A and 6B, in which thecircumferentially extending irrigation slit 72A lies in a plane at anangle of 45 to the longitudinal center axis of the irrigation tube. As amatter of fact, the embodiment of FIGS. 5A, 6A and 6B is preferred sinceit facilitates swinging of the slit end 84A of the tube off from andonto the open end of adapter 54, reduces the chance of leakage andincreases the durability of the hinge portion of the irrigation tube.Although in FIGS. 5A, 6A and 6B, the angle of the slit is 45 to thelongitudinal axis of the irrigation tube, it may, as aforesaid, be atany angle to such center line which will permit swinging of the slit end84A of the irrigation tube off from and onto the open end of theadapter. Furthermore, the slit may be curvilinear as shown by thedot-dash line 7213 in FIG. 68. Furthermore, it may have a bend in it asshown by broken line 72C in FIG. 63.

It is noted that the slit 72 and open end 76 of the catheter shank forman entry in the side of the drainage tube (the catheter adapter, as wellas the catheter, may be considered part of such tube) with a proximal(i.e., closest to the patient) portion of such tube extending in onedirection from such slit and open end and a distal (i.e., furtherestfrom the patient) portion 6 of the tubing extending in an oppositedirection from such slit and open end (this is the portion which isswung off the adapter shank). It is also noted that when the tip 90 ofthe irrigation syringe 68 is inserted into the exposed open end 76 toprovide communication between the catheter and irrigation source,communication is cut off between such proximal and distal portions sothat irrigating fluid cannot flow into such distal portion of thedrainage tube into the drainage bag but only into the proximal portionof the tubing and thence through the catheter. Accordingly, it is notnecessary to clamp the drainage tube during irrigation. This may bereferred to as a closed end to end irrigation system and it is achievedwithout the aforesaid disadvantages of a connect-disconnect arrangement.

Another less preferred way of achieving this is shown in FIGS. 19 to 22in which the shank 54a of the catheter adapter 8a is extended and isprovided with an obtuse angle bend 106 of about 135 to form a proximalpart 108 and a distal part 110 on either side of the bend, the distalend of the distal part 110 having the end of the flexible drainage tube6 extending thereover to secure the adapter to the drainage tube 6.Again, the adapter is really a part of the drainage tube. The top of thedistal portion 110 adjacent the bend has a flat area 112 having anopening or entry 114 therein, which is located at the proximal endthereof and which is axially aligned and communicates with the bore 116in the proximal part of the adapter. Actually, the opening 114 and itswall are continuations of the bore 116 and its wall, i.e., thecurvilinear contour of the wall of bore 116 continues uninterrupted tothe upper edge of the opening 114, except for the intersection therewithat 120 of the reduced diameter bore 118 of distal portion 110. Such bore116, at its upper end, and opening 114 have a slight taper inwardly asthey extend in a proximal direction. Accordingly, when the taperedirrigation tip 90 of the prepackaged irrigating syringe 68 or of anyconventional irrigating syringe is inserted into the opening 114 andbore 116, as shown in FIGS. 20 and 21 to provide irrigation, such tipfits snugly in such opening and bore to thereby cover the end 120 ofbore 118 to effectively cut off communication between the distal portion110 and proximal portion 108 of the drainage tubing. Accordingly, it isnot necessary to clamp the flexible drainage tube 6 distally of theopening or entry 114. The aforesaid snug fit provides a leakproof sealbetween the catheter adapter or drainage tube and the tip 90.

The flat 112 is provided with a pair of marginal and longitudinaloverhangs 122 which form a way for sliding movement of a flat slidingclosure 124 between close position over the opening 114 during drainage(full line position in FIGS. 19 and 21) and open position to expose suchopening 114 for irrigation (broken line position in FIGS. 19 and 21).The closure 124 is provided with a finger piece 126 to aid in slidingthe closure. The fit between the closure 124 and the way 122 is snugenough to prevent accidental movement of the closure from close positionto accidentally expose the opening during drainage.

Yet another even less preferred way of obtaining end-to-end closedirrigation without a connect-disconnect arrangement is disclosed inFIGS. 23 and 24. In this case, the adapter 8b has a bend at 130 dividingthe adapter into a proximal portion 132 having a bore 148 and a distalportion 134 having a bore 136 of substantially smaller diameter thanbore 148 and to the free end of which the flexible drainage tube 6 issecured, as shown. The proximal portion 132 has a slight axial extension137 over which is normally located during drainage a removable cap 138.Secured within the extension 136 is an annular sleeve 140 of a flexible,resilient and elastic material, such as rubber, the inner end of whichis provided with a circular disk 142 of the same material and integrallyconnected to the sleeve only at a small flexible hinge area 144 butotherwise separate from the sleeve.

The normal relaxed position of the disk 142 during drainage is shown inFIG. 23, in which position the periphery of the disk 142 engages theinner wall of the bore 148 snugly around its entire circumference.

However, when the tapered tip 90 of the irrigating syringe 68 isinserted into the open extension 137 (after removal of cap 138) itforces the disk 142 to be swung around its flexible hinge 144 into therecess 145 and over the end 146 of the bore 136 in the distal portion134 to thereby shut off communication between such distal portion andthe proximal portion 132, as shown in FIG. 24.

By tapering the disk 142, as shown, a snug fit is achieved betweenthe'tip 90 and the wall of bore 148 of 65 which the disk 142 now forms apart to provide a seal and thereby permit irrigation without leakage.Since the disk 142 is forced tightly against the end of bore 136 a sealis achieved to prevent irrigating fluid from flowing into bore 136. Theopen extension 137 comprises an entry in the side of the catheteradapter 8b, which is functionally part of the drainage tubing.

It maybe seen that with all of these embodiments irrigation can becarried out quite conveniently and simply without the aforesaidconnect-disconnect arrangement, with its attendant dangers of contamination, and without requiring a clamp for the drainage tube duringirrigation.

The slit tube irrigation arrangement of FIGS. 4-1 1 is exceedinglysimple, fool-proof, inexpensive and convenient to use. It does notbecome plugged by solids in the urine and reduces danger of retrogradeinfection to a'minimum, particularly when coupled with the enlarged,inside diameter drainage tube and the one way ball valve assembly 66 tobe hereinafter described in greater detail.

BALL VALVE ASSEMBLY 66 The one-way ball valve assembly 66 (FIGS. 12-14)within the bag 4 comprises a semi-rigid polyvinylchloride (the samematerial as the catheter adapter 8 and irrigation sleeve 74) hollowcylindrical ball housing 150 having at one end thereof a reduced endportion 152 around which the end of the drainage tube within thedrainage bag is cemented.

The intersection of reduced end portion 152 and the housing proper formsan external shoulder 154, against which the end of tube 6 abuts, and aninternal valve seat 156 formed by the intersection of the internallytapered bore 158 in reduced section 152 and the curved end portion 160of the internal bore 168 within the enlarged portion 170 of the housing.The other open end of the housing 170 is closed by a cap 151 of the samematerial as the housing and cemented thereover. Housing portion 170houses a stainless steel ball 172 and is provided with three elongated,circumferentially and equidistantly spaced longitudinal slots 174extending to the capped end, and three circumferentially andequidistantly spaced internal, tapered longitudinal ribs 176 to decreasefrictional contact of the housing with the ball.

The ribs 176 extend to the capped end of the enlarged portion 170 of thehousing and, as shown in FIG. 13, they are tapered inwardly as theyextend from such capped end.

The diameter of the stainless steel ball is substantially less than thediameter of the ball housing portion 170 but is, of course,substantially larger than the diameter of the valve seat 156. It is alsosubstantially larger than the width of the slots 174.

Ball 172 is adapted to roll freely within the housing 170 between aclosed position (shown in broken lines in FIG. 13), in which it f'u'mlyengages the valve seat 156 to close communication between the bag 4 andthe drainage tube 6 and to which it moves instantaneously in response tothe commencement of even the slightest flow of urine from the bagthrough slots 174 into the housing 170 or in response to any tilting ofthe bag which might cause such commencement of flow, and an openposition (shown in full lines in FIG. 13), in which it engages the flatinside wall of cap 151 to permit free and unrestricted flow of urinefrom tubing 6 into housing 170 and through slots 174 into the any timethere is flow of urine through the drainage tube 6 to the valve seat sothat the ball is in open position, the open cross-sectional area of eachof the slots 174 and of the seat 156 is at least as great as theinternal cross-sectional area of the enlarged drainage tube 6.Accordingly, the entire system from catheter adapter to bag has nopassage having a cross-sectional area small enough to form a continuouscolumn of urine in the tube so that the ball valve assembly 66, althougheffectively preventing reflux of urine from the bag into the tube 6,cooperates with the internally enlarged drainage tube to prevent theformation of a continuous column of urine in the drainage tube. It alsofunctions to do this because of the ease with which the ball is rolledto its normal open position. Preferably, but not necessarily, thedrainage tube 6 is secured in the edge 52 of the drainage bag so thatthe valve housing 66 is at a very slight inclination to cause the ball172 to normally occupy its open position by gravity. This insures thatthe ball valve will not normally restrict the flow of urine in theslightest. Accordingly, no force is required to open the valve seat 156so that the ball does not support the build-up of any urine column inthe drainage tube, which is a disadvantage of a valve which requires anysubstantial force to open it.

A plurality of slots 174 are used and the diameter of the ball is madeconsiderably smaller than the inside diameter of the housing 170 inwhich it rolls and the slots are elongated to insure free andunrestricted flow of liquid from the tube 6 through the housing into thebag to thereby prevent the build-up of a liquid column in the drainagetube. Actually, only one slot of the aforesaid size would be enough toprevent the formation of a continuous column of urine in the drainagetube but multiple slots provide a safety margin and also increase thesensitivity of the ball to commencement of refluxing into the housingthrough the slots. The greater the total slot area the better.

It is noted that when the ball is in open position (full lines in FIG.13) it lies in front of the slots so that any slight flow inwardlythrough the slots instantly moves the ball to close position.

In the drawings, the spherical ball 172 is 0.375 inch in diameter, thevalve seat is 0.340 inch in diameter, the inside diameter of the housingis 0.50 inch, the open length of-the slots is 0.50 inch and the width ofthe slots is 0. l6 inch.

The ribs 176 reduce friction between the ball and housing to a minimumto thereby insure free rolling of the ball in response to even theslightest force.

. The cap 151 functions as a stop for the ball. Any other kind of stopwill do and it is not essential that the open end of the housing 170 beclosed.

The polyvinylchloride housing 150, although relatively rigid hassufficient resilience and flexibility so that the ball 172 forms a goodseal with the valve seat 156.

The bore 158 of reduced diameter portion 152 is tapered inwardly as itextends toward the valve seat 156 to cause the ball to be more easilymoved away from the seat to open position by flow of urine through thedrainage tube 6 to the seat.

The ball may be made of other materials, such as plastic, as long as ithas a specific gravity substantially greater than the urine so that itwill not float and so long as it is inert to the urine.

The molded housing holds apart the flexible panels 12 and 14 of bag tothereby insure against the panels sticking together at the exit of thedrainage tube into the bag i.e., the housing insures that there willalways be a space at the exit of the drainage tube into which the urinecan freely flow. This is another reason for the plurality ofcircumferentially spaced slots, i.e., to insure against the bag panelscovering a single slot to thereby restrict such outflow. In thisrespect, it is pointed out that urine is more adhesive than water andconsequently is apt to cause the bag panels to adhere together. For thesame reason the tendency of the urine to form a meniscus in the drainagetube 6 is greater than water.

It is noted that the outside diameter of reduced end portion 152 islarger than the inside diameter of the flexible tube 6. As aforesaid,the diameter of the opening defined by valve seat 156 is eleventhirty-seconds inch like the internal diameter of the tube 6.

If desired the enlarged housing may be slightly tapered inwardly as itextends from the cap 151 to the shoulder 154.

PROTECTIVE CAP 48 FOR DRAW-OFF-TUBING 10 The semi-rigid (relativelyrigid compared to the flexible plastic draw-off-tubing 10), hollowprotective cap 48 (FIGS. 15-17) is cylindrical in shape and is made of amolded polyvinyl chloride, having the same properties as the ball valvehousing and the catheter adapter in that it has more resilience andflexibility as compared, for example, to polystyrene. It is made up ofan enlarged diameter hollow part having an enlarged bore 191 therein anda reduced diameter hollow part 182 having a reduced diameter bore 188within which the beveled end portion 184 of the flexible plasticdraw-off-tubing 10 is snugly received in a liquid-tight and air-tightmanner with the comer 186 of the beveled end 62 of the draw-off-tube 10in engagement with the internal shoulder 186a within the bore 188.

The enlarged portion 180 has an integral internal hollow tubular tip 190therein extending integrally,

coaxially and longitudinally thereinto from the end of portion 180adjacent to reduced portion 182 but terminating a substantial distancefrom the opposite open end 181 of portion 180 so that the free end oftip 190 is located well within the portion 180, as shown in FIG. 16. Theexternal periphery of the tip 190 is tapered and is spaced radiallyinwardly from the internal surface 191 of the enlarged portion 180.

The wall of the internal bore of the tip 190 is axially aligned with thewall of the bore of the draw-off-tube 10 and is of the same diameter sothat when the drawoff tube 10 is located in the cap 48, as shown in FIG.16, the tip 190 constitutes an extension of the draw-offtube 10 and maybe considered as a part thereof.

The dimensions of the periphery of tip 190 and of the space 192 betweensuch periphery and the internal surface of the portion 180 are such thatwhen the cap 48, with the draw-off-tube 10 located therein, is placedover the end portion 194 of the stabilizing tube 42 protruding beyondthe edge 34 of the pocket 32, the

tapered tip 190 is received snugly '1 'thin the end 46 of thestabilizing tube with a liquid-tight and air-tight fit and the enlargeddiameter part'l80 of the cap is located around, but radially spacedfrom, such end of the stabilizing tube, as shown in FIG. 16. Theresilience and flexibility of the tip 190 and stabilizing tube 42,together with the: external taper'of the tip, provides an excellent sealtherebetween while at the same time permitting the cap'48 to be easilyplaced over the end of the stabilizing tube during normaluse and to beeasily removed therefrom to draw urine from the bag 4.

The aforementioned close fit between tip 190 and the end of thestabilizing tube and between the drawoff-tube l and the internal surfaceof the reduced diameter portion 182 of the cap insures against the entryof contaminants into the system, against leakage of sterilizing gasduring sterilization and against leakage of urine in the event thaturine should overflow up the draw-off-tube into the stabilizing tube.

If desired, the draw-off-tube 10 can be sealed in the cap.

The open end 181 of the cap is preferably beveled, as shown.

It may be seen that when the draw-off-tube 10 is removed from thestabilizing tube, as shown in broken lines in FIG. 1, to draw off urinefrom the bag, the protective cap 48, i.e., the enlarged housing 180,protects the end 190 of the draw off tube 10-190 fromcon tamination bycontact with contaminated objects, in cluding the fingers, while at thesame time improving the seal between the draw-off-tube and stabilizingtube when the draw-off-tube is located in the stabilizing tube duringdrainage.

A less preferred way of obtaining generally the same effect is toeliminate the tip 190, with the end portion 184 of the flexibledraw-off-tubing being inserted in the cap so that the corner 186 thereofis located in the same position as the end of tip 190 in FIG. 16. Insuch case, the external surface of such draw-off-tube within theenlarged portion 180 is spaced radially inwardly from the internalsurface of portion 180 the same distance as the external surface of thetip 190 is spaced from such internal surface in FIG. 16 and theend'portion 184 of the draw-off-tube is received snugly within the endof the stabilizing tube.

In such case, the space between the external surface of thedraw-off-tube within portion 180 and the inside surface of portion 180may be such that the end of the stabilizing tube is snugly grippedtherebetween, or the end portion 184 of the draw-off-tube 10 may betapered and of the same size as the tip 190 to thereby cooperate withthe end of the stabilizing tube in the same way.

The internal diameter of the draw-ofl-tube is a standard ninethirty-seconds inch which is smaller than the inside diameter of thedrainage tube 6 although it may be of the same size or larger.

The draw-off-tube 10 is provided witha conventional external clamp 11which is normally open during drainage when the draw-ofi-tube is in theposition shown in full lines in FIG. 1.

The overflow provided by the draw'off-tube-stabilizing tube routecooperates with the other features described above to insure againstretrograde infection.

The irrigation sleeve 74, ball valve housing 150 and cap 151 andprotective cap 48 may be colored, e.g., yellow, to designate by colorcode the vital areas so far as retrograde infections is concerned. Thisis done in the commercial embodiment.

Also in the commercial embodiment, the stabilizer tube is colored blueand the transparent or translucent bag panel is provided withgraduations to indicate the amount of urine in the bag at any time.Irrigation Bottle 68 Irrigation bottle-syringe 68 is cylindrical inshape and is made of an autoclavable, flexible, resilient and elasticcopolymer of propylene and ethylene in which propylene constitutes themajor constituent.

It is prepackaged with sterile irrigating fluid, e.g., water or salinesolution (the syringe tip'90 and internal surface of the bottle-syringe68 are also sterile) and is sealed by an elongated rigid cap 200 ofpolypropylene located over the syringe tip and threaded over thethreaded base 202 of the tip 90 by cooperating internal threads 205 onthe cap so that the end 204 of the tip 90 is pressed tightly against thesealing disk 206 of compressible material, e.g., rubber, to provide anair-tight and liquid-proof seal, as described in my aforesaid copendingapplication. A whiskey seal may be used between cap and bottle at thethreaded areas to make the unit tamper-proof, as described in suchcopending application.

The syringe-bottle 68 has sufficient rigidity to hold its shape but issufficiently flexible, resilient, yieldable and elastic to be easilysqueezed by the fingers to eject the fluid. It is elastic enough toreturn to its normal shape after squeezing so that the fluid can beeasily aspirated out of and into the syringe and into and out of thebladder to irrigate.

The syringe tip 90 is more rigid than the syringe proper and, asaforesaid, is of such dimension that it can be inserted into the exposedopen end 76 of the catheter adapter shank 54 to a point at which itsperiphery engages such open end to form an excellent friction fit andseal during irrigation.

The optimum thickness of the wall of the syringe proper is between 0.025and 0.030 inch. The maximum thickness is preferably about 0.035 inch andthe minimum preferably about 0.020 inch.

The syringe 68 is of a size to fit within the palm of the hand and has aflat bottom or the equivalent (e.g., centrally dished) to permit it tobe placed on a supporting surface without tipping. The syringe is alsoprovided with graduation marks.

The present invention is not only useful for drainage from,and'irrigation of, the bladder but can also be used for closed systemdrainage from, and closed system irrigation of, other body cavities.

It is'not intended that the invention be limited to the constructionsshown and described in the accompanying drawings and the abovedescription but only to those constructions which are claimed below andtheir equivalents.

I claim:

1. In a system for draining and irrigating a body cavity, tubing fortransporting fluids from said body cavity, said tubing having an entryin the side thereof and comprising a distal portion extending in onedirection from said entry and a proximal portion extending in an op-

1. In a system for draining and irrigating a body cavity, tubing fortransporting fluids from said body cavity, said tubing having an entryin the side thereof and comprising a distal portion extending in onedirection from said entry and a proximal portion extending in anopposite direction from said entry, closure means for said entry, saidclosure means being movable to alternately expose said entry forirrigation and close saiD entry for said transporting of said fluids,said entry being positioned so that when it is exposed, the tip of anirrigating source may be inserted thereinto to force fluid from theirrigating means through said proximal portion to said body cavitywithout leakage while at the same time cutting off communication betweensaid distal and proximal portions, said entry comprising acircumferential slit in said tubing extending around part of thecircumference thereof, the unslit part of said circumference comprisinga hinge about which the slit ends of said tubing can be swung away fromeach other so that said tip can be inserted in the slit end adjacentsaid proximal portion in a liquid tight manner whereby communication iscut off between said slit ends, said closure means normally holding saidslit ends against said swinging movement and in a manner to permit flowof fluid through said slit portion of said tubing without leakage.
 2. Ina system for transporting fluids in the medical and surgical fields,tubing having a slit extending peripherally around a substantial part ofthe periphery thereof, the slit ends being movable away from each otherto expose the interior of said tubing and means for normally preventingsaid slit ends from substantial movement away from each other butoperable to permit said movement.
 3. In a system for transporting fluidsin the medical and surgical fields, tubing having a slit extendingperipherally around a substantial part of the periphery thereof andmeans for normally preventing said slit ends from substantial movementaway from each other but operable to provide for said movement, theunslit portion of said circumference forming a flexible and resilienthinge about which the slit ends of said tubing can be swung away fromand toward each other, said preventing means comprising a protectivemember normally located over said slit portion of said tubing to holdsaid slit ends against said swinging movement and movable along saidtubing to expose said slit for said swinging movement.
 4. In a systemfor transporting fluids in the medical and surgical fields, a tubinghaving a slit extending circumferentially around a substantial part ofthe circumference thereof, the unslit portion of said circumferenceforming a flexible and resilient hinge about which the slit ends of saidtubing can be swung away from and toward each other, a relatively rigidtubular member, at least an end portion of which fits snugly within saidslit portion of said tubing with the slit located at a distance from theend of said member so that the slit end of said tubing extending beyondsaid end of said member can be swung about said hinge off said end ofsaid member to expose said end, and a protective sleeve fitted over saidslit portion of said tubing and slidable along the outside of saidtubing to expose the slit for said swinging motion.
 5. In a systemaccording to claim 4, said slit extending circumferentially at an angleof less than 90* to the longitudinal center line of said tubing.
 6. Asystem according to claim 5, said angle being about 45*.
 7. In a systemaccording to claim 4, said tubular member having means for holding saidsleeve over said slit against accidental sliding movement which willexpose said slit.
 8. In a system according to claim 7, said holdingmeans comprising an annular skirt extending from the periphery of saidmember to form an annular recess for snugly receiving an end of saidsleeve to hold it over said slit.
 9. In a system according to claim 4,said system being a urinary drainage and irrigation system, said tubebeing a urinary drainage tube, said member being the shank of a catheteradapter.
 10. A system according to claim 9, said end of said shank whenexposed by said swinging movement being adapted to receive the tip of anirrigation source in a substantially fluid-tight manner to providecommunication between said irrigation source and said adapter and cutoff communication between sAid adapter and the distal portion of saidtube beyond said slit.
 11. A system according to claim 10, said tubingbeing attached to a urinary drainage bag.
 12. A system according toclaim 11, said system being a closed system, said bag being adisposable, flexible and collapsible plastic bag to which said drainagetube is sealed.
 13. A system according to claim 10, including saidirrigating source, said irrigating source being a syringe having anexternally tapered tip which is dimensioned to engage said exposed endof said shank when inserted therein to form a seal therewith duringirrigation.
 14. A system according to claim 13, said syringe comprisinga bottle made of a flexible, resilient and autoclavable plastic in whichsterilized irrigating fluid is prepackaged, said tapered tip comprisinga neck extending from the top of said bottle, said bottle having a capadapted to be normally secured over said tip in sealing relationshiptherewith to seal said bottle.
 15. A system according to claim 4, saidsystem being a urinary drainage system, said tube being a urinarydrainage tube, the inside diameter of said tube being greater than themaximum diameter at which a continuous column of said fluid will form insaid tube.
 16. A system according to claim 15, said inside diameterbeing greater than nine thirty-seconds inch.
 17. A system according toclaim 4, said system being a urinary drainage system and said tube beinga urinary drainage tube, an end of said drainage tube extending into adrainage bag, said end of said drainage tube being provided with a oneway ball valve comprising an elongated housing, one end of which issecured to said end of said drainage tube and has a valve seat and theother end of which is provided with a stop, said housing having anopening therein, a ball in said housing adapted to roll longitudinallytherein between a close position, in which it engages said valve seat toclose communication between the bag and tube and to which it moves inresponse to commencement of fluid flow from said bag into said housing,and an open position in which it engages said stop at said other end ofsaid housing to permit flow of fluid from said tubing into said housingthrough said valve seat and thence through said opening into said bagand to which it is moved in response to flow of fluid from said tube tosaid valve seat.
 18. A system according to claim 17, the freecross-sectional areas of said opening and said valve seat being greaterthan the maximum cross-sectional area of said tube at which a continuouscolumn of said fluid will form in said tube during flow of said fluidthrough said tube.
 19. A system according to claim 4, said system beinga urinary drainage system, said tube being a urinary drainage tube, anend of said drainage tubing extending into a drainage bag, said baghaving draw-off-tubing means for drawing fluid from said bag, the freeend of said draw-off-tubing means having a protective cap securedthereto, said protective cap having a housing which extends around andbeyond the end of said draw-off-tubing means and which has an internaldiameter greater than the outer diameter of said draw-off-tubing means,whereby the inner surface of said housing is radially and outwardlyspaced from the outer surface of said end of said draw-off-tubing meansto thereby prevent said end of said draw-off-tubing means from cominginto contact with contaminated objects.
 20. A system according to claim19, said end of said draw-off-tubing means being adapted to be snuglybut slidably received in an end of a relatively rigid stabilizing tubeextending along the top portion of said bag with the end of saidstabilizer tube being received in an annular recess between said end ofsaid draw-off-tubing means and said housing.
 21. A system according toclaim 12, the inside diameter of said drainage tube being greater thanthe maximum diameter at which a continuous column of said fluid willform in said tube, an end of said drainage tube extenDing into saiddrainage bag, said end of said drainage tube being provided with a oneway ball valve comprising an elongated housing, one end of which issecured to said end of said drainage tube and has a valve seat and theother end of which is provided with a stop, said housing having alongitudinal slot therein, a ball in said housing adapted to rolllongitudinally therein between a closed position, in which it engagessaid valve seat to close communication between the bag and tube and towhich it moves in response to commencement of fluid flow from said baginto said housing, and an open position in which it engages said stop atsaid other end of said housing to permit flow of fluid from said tubeinto said housing through said valve seat and thence through said slotinto said bag and to which it is moved in response to flow of fluid fromsaid tube to said valve seat, the free cross-sectional areas of saidslot and said valve seat being at least as large as the insidecross-sectional area of said drainage tubing.
 22. A system according toclaim 21, said bag having draw-off-tubing means for drawing fluid fromsaid bag, the free end of said draw-off-tubing means having a protectivecap secured thereto, said protective cap having a housing which extendsaround and beyond the end of said draw-off-tubing means and which has aninternal diameter greater than the outer diameter of saiddraw-off-tubing means, whereby the inner surface of said housing isradially and outwardly spaced from the outer surface of said end of saiddraw-off-tubing means to thereby prevent said end of saiddraw-off-tubing means from coming into contact with contaminatedobjects.
 23. A system according to claim 22, said end of saiddraw-off-tubing means being adapted to be snugly but slidably receivedin an end of a relatively rigid stabilizing tube extending along the topportion of said bag with the end of said stabilizer tube being snuglyreceived in an annular recess between said end of said draw-off-tubingmeans and said housing.
 24. In a system for draining fluids from a bodycavity including a drainage tube for transporting said fluids, theimprovement comprising increasing the internal diameter of said tube toa size at which said fluid flows freely through said tube withoutforming a continuous column of said fluid in said tube, said systembeing a urinary drainage system and said tube being a urinary drainagetube, an end of which is provided with a catheter adapter, said bodyfluid being urinary fluid and said tube having an internal diametergreater than the maximum internal diameter at which a continuous columnof said urinary fluid will form in said tube during flow of said urinaryfluid through said tube and from said catheter adapter by gravity, saiddrainage tube being of a flexible plastic, the other end of saiddrainage tube extending into a closed system plastic drainage bag, saidother end of said tube being provided with a one way check valvecomprising a housing one end of which is attached to said other end ofsaid drainage tube and has a valve seat and the other end of which isprovided with a stop, said housing having an opening and a ball locatedtherein adapted to roll freely between a closed position at said one endof said housing, in which it engages said valve seat to seal the tubefrom the bag, and an open position at said other end of the housing inwhich it engages said stop and in which fluid can flow from said tubeinto said housing through said valve seat and thence through saidopening into the bag, said ball being responsive to the commencement offlow of fluid from said bag into said housing to roll to said closedposition to shut off said flow and being responsive to said flow offluid in said tube to said valve seat to roll to said open position tothereby provide for free flow of fluid from said tube into said bag. 25.A system according to claim 24, the cross-sectional areas of saidhousing opening and the valve opening defined by said valve seat and thehousing being at least as great as the cross-sectional area of saiddrainage tube.
 26. A system according to claim 25, the diameter of saidball being substantially smaller than the inner diameter of saidhousing.
 27. In a urinary drainage system having a drainage tubing withan end extending within a drainage bag, a one way ball valve located atsaid end of said tubing to permit free flow of fluid from the tubinginto the bag but to prevent any substantial reflux flow from the bagback through the tubing, said valve comprising a hollow housing, one endportion of which is secured to said end of said tubing and has a valveseat and the other end portion of which is provided with a stop, saidhousing having an opening therein, a ball in said housing adapted toroll therein between a close position in which it engages said valveseat to close communication between the bag and tubing and to which itmoves in response to commencement of fluid flow from said bag into saidhousing, and an open position in which it engages said stop to permitfree flow of fluid from said tubing into said housing and through saidopening into said bag and to which it is moved in response to fluid flowfrom said tubing to said valve seat, the diameter of said ball beingsubstantially smaller than the internal diameter of said housing so asnot to interfere with flow of fluid through said housing and opening,said ball having a specific gravity substantially greater than saidfluid and being substantially inert to said fluid.
 28. In a urinarydrainage system according to claim 27, said one end portion of saidhousing extending into a reduced diameter portion to which said tubingis secured, said opening comprising an elongated slot extendinglongitudinally of said housing.
 29. In a urinary drainage systemaccording to claim 28, said valve seat being formed by the intersectionof said reduced diameter portion and said housing.
 30. A bag accordingto claim 27, having longitudinal internal ribs for guiding said rollingmovement of said ball and for reducing friction between said ball andhousing.
 31. A bag according to claim 27, having a plurality of saidopenings, each opening comprising a slot which is elongated and whichextends longitudinally of said housing, said stop comprising a closedend of said housing, said housing being of plastic and said ball being astainless steel ball.
 32. In a urinary drainage system having drainagetubing for transport of fluid, a bag for collection of said fluid fromsaid drainage tubing and draw-off-tubing means for removing fluid fromsaid bag, the free end of said draw-off-tubing means having a protectivecap secured thereto, said protective cap comprising a housing whichextends around and beyond said end of said draw-off-tubing means andwhich has an internal diameter substantially greater than the outerdiameter of said draw-off-tubing means, whereby the internal walls ofsaid housing are spaced radially and outwardly from the external wall ofsaid end of said draw-off-tubing means received in said housing, wherebysaid end of said draw-off tubing means is protected by said cap fromcontamination by contact with contaminated objects.
 33. In a systemaccording to claim 32, said bag being flexible and having a tubularmember which is more rigid than said bag, which is affixed to said bagand an end of which is adapted to snugly but removably receive said endof said draw-off-tubing means, the external diameter of saiddraw-off-tubing means cooperating with the internal diameter of said endof said tubular member so that when said end of said draw-off-tubingmeans is received in said end of said tubular member, said end of saidtubular member is snugly received between the outer surface of said endof said draw-off-tubing means and the inner surface of said housing. 34.In a system according to claim 33, said housing having a reduceddiameter end portion adapted to snugly receive said draw-off-tubingmeans with said end thereof extending into said enlarged housing.
 35. Ina system according to claim 33, the external wall of said end of saiddraw-off-tubing means being tapered to provide a snug sealing fit withthe internal surface of said end of said tubular member.
 36. In a systemaccording to claim 33, said bag being a disposable plastic urinarydrainage bag, said tubular member being a relatively rigid tube locatedlaterally along the upper portion of said bag to stabilize the bag. 37.In a system according to claim 32, said draw-off-tubing means comprisinga main flexible portion extending from and sealed to said bag and a tipportion, which is integral with said cap but separate from said mainportion, said tip portion comprising said end of said draw-off-tubingmeans which is spaced radially inwardly from the inner surface of saidhousing.
 38. In a system according to claim 32, said draw-off-tubingmeans being a soft plastic tube and said cap being a plastic cap, whichhas a greater rigidity than said draw-off-tubing means, said housinghaving an end portion of reduced internal diameter for snugly receivingthe end of said main portion.
 39. A system according to claim 32, saidurinary drainage tubing being larger in internal diameter than saiddraw-off-tubing means.
 40. A system according to claim 32, said urinarydrainage tube having an internal diameter greater than the maximumdiameter at which a continuous column of fluid will form in saiddrainage tubing.
 41. A system according to claim 32, an end of saiddrainage tube being located in said bag, said end of said drainage tubehaving a one way ball valve attached thereto comprising a housing at oneend of which is formed a valve seat and at the other end of which isformed a stop and a ball located in said housing and adapted to rollbetween a close position at said one end of said ball housing in whichit engages said valve seat to seal the drainage tube from the bag and anopen position at the other end of the ball housing in which it engagessaid stop and in which fluid can flow freely from the drainage tube intothe housing and thence into the bag.